Efficacy and Safety of Botulinum Toxin at Moderate to Severe Glabellar Lines

A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Compare the Efficacy and Safety of ATGC-100 Versus Botox in Subjects With Moderate to Severe Glabellar Lines

Efficacy and safety of ATGC-100 are assessed in subjects with moderate to severe glabellar lines.

Study Overview

• Status: Completed
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Biological: ATGC-100 100U; Biological: Botox 100U

• Study Type: Interventional
• Enrollment (Actual): 290
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Nowon Eulji University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy male and female aged 19 to 65 years old
2. Participants with Facial Wrinkle Scale (FWS) score of > 2 at maximum frown at screening
3. Participants willing to follow the study procedures and schedules
4. Participants willing to give written informed consent to participate in the trial

Exclusion Criteria:

1. Participants with severe glabellar lines that cannot be improved physical method
2. Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
3. Participants with known hypersensitivity to any component of the study drug
4. Participant who has skin disorder including infection and scar on injection site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ATGC-100 100U; ATGC-100 will be injected to 5 glabellar lines (each 4U/0.1mL; total 20U) at Day 0	Biological: ATGC-100 100U; Clostridium botulinum toxin type A
Active Comparator: Botox 100U; Botox inj. will be injected to 5 glabellar lines (each 4U/0.1mL; total 20U) at Day 0	Biological: Botox 100U; Clostridium botulinum toxin type A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with improvement of glabellar lines at maximum frown	Improvement rate of glabellar lines at maximum frown with Physician's Facial wrinkle scale (FWS)	4 weeks post injection compared to baseline

Collaborators and Investigators

• Sponsor: EuBiologics Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CBA-PLN-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No